Novo Nordisk's Denecimig Biologics License Application Under Extended US FDA Review

03:54 AM EDT, 10/04/2026 (MT Newswires) -- Novo Nordisk's (NOVO-B.CO) biologics license application for denecimig as a treatment of haemophilia A, with or without inhibitors in adults and children, is still under review at the US Food and Drug Administration. Filed in September 2025, the BLA is being evaluated because of pending facility remediation activities. Meanwhile, the drug regulator did not indicate any deficiencies related to the BLA's clinical efficacy or safety data, according to an Oct. 2 release. While the FDA did not stipulate a timeline for regulatory action, the Danish drugmaker is addressing the manufacturing facility remediation requests, with an aim to roll out denecimig in the US in the first half of 2027. The extended review does not affect Novo's financial outlook for 2026.